Table 1 Definition of adverse events and reactions according to EU clinical trial directive 2001/20

Adverse Event (AE)

Any untoward medical occurrence in a patient or clinical trial subject to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product.

Adverse Reaction (AR)

Any untoward and unintended response to an investigational medicinal product related to any dose administered.

Unexpected Adverse Reaction (UAR)

An adverse reaction, the nature or severity of which is not consistent with the information about the medicinal product in question set out in the summary of product characteristics (or Investigator brochure) for that product.

Serious Adverse Event (SAE), Serious Adverse Reaction (SAR) or Suspected Unexpected Serious Adverse Reaction (SUSAR)

Respectively, any adverse event, adverse reaction or unexpected adverse reaction that:

● results in death

● is life-threatening

● requires hospitalization or prolongation of existing hospitalization

● results in persistent or significant disability or incapacity

● consists of a congenital anomaly or birth defect¹

● is any other important medical event(s) that carries a real, not hypothetical, risk of one of the outcomes above